{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T21:34:14Z","timestamp":1770327254398,"version":"3.49.0"},"reference-count":52,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2023,6,27]],"date-time":"2023-06-27T00:00:00Z","timestamp":1687824000000},"content-version":"unspecified","delay-in-days":26,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Heinsius Houbolt Fund","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,6,13]]},"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Cochlear implantation (CI) is a (cost-)effective intervention for people with severe or profound hearing loss. Since its introduction experience increased and the technology evolved, leading to better results and relaxation of CI eligibility criteria. Meanwhile, with national healthcare costs increasing there is a need for evidence of healthcare technology\u2019s value. This protocol describes a study to investigate clinical and participatory outcomes after CI for the currently (expanded) eligible hearing impaired population. The study adds to the current evidence base through its multicentre design, long-term follow-up and use of participatory outcomes alongside standard clinical outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This multicentre prospective observational cohort study will include at least 156 adult patients with severe-to-profound hearing loss, approximately evenly divided into two groups (1, ages 18\u201365 years and 2, age &gt;65 years). The measurements consist of audiometry, cognition tests, listening effort tests and multiple generic and disease specific questionnaires. Questionnaires will be administered twice before CI, soon after inclusion at CI referral and shortly before CI surgery, with an annual follow-up of 3 years after CI. The Impact on Participation and Autonomy questionnaire will be used to assess participation. Generalised models (linear, logistic, Poisson) will be used. Mixed effects models will be used to investigate changes over time while exploring differences in subgroups and the influence of covariates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study has received ethical approval from the Medical Ethical Committee of all participating centres. The results could provide valuable insights into changes in participatory outcomes of people with severe-to-profound hearing loss after CI. Results will be disseminated through peer-reviewed journals, scientific conferences and professional and patient organisation meetings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05525221\">NCT05525221<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-072689","type":"journal-article","created":{"date-parts":[[2023,6,27]],"date-time":"2023-06-27T12:17:39Z","timestamp":1687868259000},"page":"e072689","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study \u2013 Societal Merit of Intervention on Hearing Loss Evaluation (SMILE)"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct05525221","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2184-1090","authenticated-orcid":false,"given":"Hugo G B","family":"Nijmeijer","sequence":"first","affiliation":[{"name":"Department of Otorhinolaryngology, Radboudumc, Nijmegen, Netherlands"},{"name":"Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wendy J","family":"Huinck","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Radboudumc, Nijmegen, Netherlands"},{"name":"Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0451-8179","authenticated-orcid":false,"given":"Sophia E","family":"Kramer","sequence":"additional","affiliation":[{"name":"Otolaryngology-Head and Neck Surgery, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands"},{"name":"Amsterdam Public Health Research Institute, Amsterdam UMC, Amsterdam, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A Rogier T","family":"Donders","sequence":"additional","affiliation":[{"name":"Department for Health Evidence, Radboudumc, Nijmegen, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gert Jan","family":"van der Wilt","sequence":"additional","affiliation":[{"name":"Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, Netherlands"},{"name":"Department for Health Evidence, Radboudumc, Nijmegen, 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